1. Field of the Invention
This invention relates to devices and methods for percutaneous puncture treatment under fluoroscopic monitoring.
2. Description of the Prior Art
Percutaneous drainage is a technique for treating patients by puncturing the skin or cutaneous layer of the patient to drain fluid from an area inside the patient. For example, fluid can build up due to a plugged liver duct. A needle is inserted through the skin into the liver and the fluid is aspirated through a hollow passage in the needle.
In order to properly locate the needle, the patient is viewed with a fluoroscope during insertion of the needle. The organ to be punctured is usually treated with a dye which will cause the organ to appear on the fluoroscope. Because of the dangers associated with continual exposure to radiation from a fluoroscope, a doctor cannot handle the needle while the fluoroscope is activated. Therefore, the needle is usually held with a clamp during insertion. The needle is held a short distance from its puncturing tip with a long clamp, so that the doctor's hands are outside of the x-ray beam. The needle is then inserted through the skin or cutaneous layer. The needle is inserted perpendicular to a fluoroscopic field of view, so that the path of the needle can be followed on the fluoroscope monitor.
Because the needle is metallic, it is radiopaque and therefore visible on the fluoroscope monitor. The doctor can follow its path insertion and tell whether it is going straight. The fluoroscopic field of view is essentially perpendicular to the hollow passage in the needle, so that a straight insertion (i.e., parallel to the axis of the fluoroscope's x-ray beam) will result in a round view of the cross section of the needle. If the needle is oriented at an angle with respect to the axis of the x-ray beam, the doctor will see an elongated oval cross section rather than the round cross section.
Because of the difficulty in holding the needle with a long clamp, and because the needle typically used in the past has a bevelled tip which causes lateral deflection of the needle during insertion, in the prior art the needle can only be inserted a short distance at a time. The patient is instructed to hold his breath, and the needle is pushed in a short distance. The fluoroscope is then turned off so that the doctor can rotate the needle by 180.degree. so that the orientation of the bevelled tip is reversed and can readjust the clamp another short distance up the needle. The fluoroscope is rotated to a horizontal position in order to determine whether the needle is still directed towards the proper area of the organ to be aspirated. Each time the patient breathes, the internal organ shifts slightly. It does not always return to the exact position it occupied prior to the breath. Therefore, for each small step of insertion the position of the organ relative to the needle must be checked in both the vertical and horizontal axes.
The incremental process repeats until the needle reaches the organ. In each step the patient suspends respiration, the doctor inserts the needle a short distance while viewing progress on the fluoroscope, the fluoroscope is turned off, the clamp is adjusted, the fluoroscope is rotated to check horizontal position, the fluoroscope is rotated back to the vertical, and the fluoroscope is reactivated to view the insertion of the needle. This laborious process involving many operations is required because of the difficulty in transmitting force to the needle from a distantly-held clamp without causing deflection of the needle from the desired path.
A patient search on the present invention uncovered the following United States patents:
______________________________________ Inventor U.S. Pat. No. Issue Date ______________________________________ Thaxton 2,737,957 03/13/56 Carey et al 3,702,935 11/14/72 Rodriguez 3,812,842 05/28/74 Wilson et al 4,005,527 02/01/77 Kvavle et al 4,007,732 02/15/77 Bade 4,091,497 05/30/78 Jones 4,202,349 05/13/80 ______________________________________
U.S. Pat. No. 2,737,957 to Thaxton shows an elongated cross bar handle on a pipe cleaner.
U.S. Pat. No. 4,091,497 to Bade shows a tool handle constructed of plastic.
U.S. Pat. No. 3,702,935 to Carey et al discloses a mobile fluoroscopic unit which is used for positioning vascular catheters.
U.S. Pat. No. 3,182,842 to Rodriguez discloses an indexing scale which is mounted on the exterior of a patient's body. The scale has lead inlay lines and a movable lead inlay indicator. The lead parts are visible on the x-ray. The indicator is positioned to indicate the location of a vessel relative to the scale for catheterization.
U.S. Pat. No. 4,005,527 to Wilson et al. shows a depth gauge having alternating x-ray opaque and x-ray transparent sections of predetermined length. The depth gauge is inserted in a bone joint and viewed from the side with x-ray techniques to determine the distance into the joint which has been drilled.
U.S. Pat. No. 4,007,732 to Kvavle et al discloses a biopsy tool in which a wire with a barbed target is implanted in a breast. The target is held in place by the barbs. A wire extends from the target out through the cutaneous layer. A cutting tool with a central bore is then mounted over the wire and is guided by the wire in its cutting of tissue.
U.S. Pat. No. 4,202,349 to Jones discloses a radio-opaque blood vessel marker which is mounted on side wall portions of a blood vessel. Pulsation of the side walls of the vessel due to blood flow can be detected by fluoroscopic examination of the markers.